RE:RE:RE:RE:New Press Release - Oncolytics Biotech® Announces Productive FDA Type C Meeting on its Metastatic Breast Cancer ProgramCorrection: Earlier ONCY reported that the confirmed overall response rate (ORR) at 1 year was 37.5% for the pelareorep-paclitaxel doublet vs. 13.3% with paclitaxel monotherapy.
In June 2023 ONCY reported " “BRACELET-1’s positive results complement prior phase 2 data showing a statistically significant increase in overall survival when pelareorep was combined with paclitaxel by demonstrating similar robust improvements in PFS and ORR in less heavily pre-treated patients,” said Dr. Matt Coffey, President and Chief Executive Officer.
“Given this exciting finding, our next step is to discuss our data with the FDA to investigate incorporating dual PFS and OS endpoints into our breast cancer program’s registrational study. Including a PFS endpoint could substantially reduce the time to a pivotal readout from the registrational trial, thereby accelerating pelareorep’s path to potential approval as we work to address the urgent needs of HR+/HER2- breast cancer patients.”